NCT03554746

Brief Summary

Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

May 30, 2018

Results QC Date

September 17, 2018

Last Update Submit

September 17, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Leg Length Inequality

    functional leg length inequality

    change from baseline at 6 weeks later

  • Ilium Anterior Tilt Difference

    bilateral ilium anterior tilt difference

    change from baseline at 6 weeks later

  • Pelvic Inclination

    bilateral pelvic inclination

    change from baseline at 6 weeks later

Secondary Outcomes (3)

  • Pain Intensity

    change from baseline at 6 weeks later

  • Functional Disability

    change from baseline at 6 weeks later

  • Functional Ability

    change from baseline at 6 weeks later

Study Arms (2)

GC group

EXPERIMENTAL

It mainly involve core stability exercise, stretching exercise and gluteal control training. All of above will be arranged 3 times a week for a total 6 weeks.

Other: GC group

CG group

EXPERIMENTAL

It involve core stability exercise and stretching exercise. All of above will be arranged 3 times a week for a total 6 weeks.

Other: CG group

Interventions

1. core stability training: hold 5s/rep, 20 reps/times 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times 1. Hamstring 2. Quadriceps 3. Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times 1st to 2nd: 1. clam ex. without resistance 2. single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th: <!-- --> 1. maintain 3rd to 4th ex. 2. single leg standing on rock board to maintain balance 6th: <!-- --> 1. maintain 5th ex. 2. lunge ex. without hip internal rotation

Also known as: Additional gluteal muscle control training
GC group

1. core stability training: hold 5s/rep, 20 reps/times 1. supine, pelvic posterior tilt with TrA contraction. 2. supine, pelvic posterior tilt and maintain bil. knee on 90 degrees. 3. All four position with leg raise 2. Stretching ex. : hold 15 s/reps, 5 reps/times 1. Hamstring 2. Quadriceps

Also known as: General core strengthening
CG group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-specific LBP (from inferior rib margin to the gluteal fold)
  • more than 3 months
  • Visual Analog Scale ≧5 (in past one month)
  • pelvic innominate rotation (anterior rotation in dominant side)

You may not qualify if:

  • history of fracture or surgery
  • congenital anomalies in the spine, pelvis, or lower limbs
  • recent trauma, tumor, pregnancy or scoliosis
  • lower extremity paresthesia, unknown weakness
  • bowel and bladder dysfunction
  • predominant lower extremity pain with standing
  • presence of system illness, no reasoning weight loss, predominant night pain
  • specific sacroiliac joint dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University

Taipei, 11221, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Yi-Fen Shih
Organization
National Yang Ming University

Study Officials

  • Yi-Fen Shih, PhD

    Department of Physical Therapy and Assistive Technology, National Yang-Ming University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 13, 2018

Study Start

December 11, 2017

Primary Completion

July 23, 2018

Study Completion

September 10, 2018

Last Updated

September 19, 2019

Results First Posted

September 19, 2019

Record last verified: 2019-08

Locations